Mallinckrodt plc reports the submission of a 510(k) premarket notification application to the  US FDA for an investigational inhaled nitric oxide delivery system for INOmax (nitric oxide) gas, for inhalation.

The safety and efficacy of the investigational inhaled nitric oxide delivery system has not been evaluated by the FDA.

INOmax (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.1 (Please see the Mallinkrodt website for Important Safety Information for INOmax.)

“This FDA submission marks an important milestone in our commitment to providing advancements in the delivery of our products to help improve clinician experiences,” said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We look forward to working closely with the FDA during the regulatory review process.”

If 510(k) cleared, the next-generation inhaled nitric oxide delivery system would be the latest in a long line of dual channel delivery systems; would combine automation, integration and interaction in one device; and build on Mallinckrodt’s dedication to meeting clinicians’ evolving needs.2

INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.1,3

Mallinckrodt is committed to providing support to healthcare professionals utilizing the INOmax delivery systems. Mallinckrodt provides access to INOmax Total Care offerings whose goal is to help critical care clinicians face unexpected challenges in the NICU by providing comprehensive, 24/7/365 service, device training, and INO delivery support when and where they need it. For more information about INOmax, please visit INOmax.com.

The investigational inhaled nitric oxide delivery system is not available for sale, distribution or use.

References

  1. INOmax. Package Insert. INO Therapeutics LLC; 2021.
  2. Data on File – Ref-05943. Mallinckrodt Pharmaceuticals.
  3. Data on File – Ref-01753. Mallinckrodt Pharmaceuticals.